BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ ®RX TAPERED CAROTID STENT

    MDR report key: 2881713 · Received December 20, 2012

    Report

    Report Number
    2183870-2012-00242
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    August 30, 2012
    Report Date
    December 6, 2012
    Manufacturer
    EV3 INC.
    Product Code
    NIM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTE EVENT. (B)(4): STENT IMPLANTED (B)(6) 2012.

    Description of Event or Problem · 1

    THIS PROCEDURE IS PART OF (B)(6):THE PROTEGE RX WAS PLACED, BUT THERE WAS A GEOGRAPHIC MISS, SO A SECOND PROTEGE STENT WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTÉGÉ ®RX TAPERED CAROTID STENT STENT, CAROTID NIM EV3 INC. SECX-10-7-40-135 9613875

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention